Sentec
Mechanical Engineer - Sustaining Engineering
Sandpoint, Idaho, United States
Sponsorship not specifiedDetected 12 days ago
ComplianceSolidWorksCreoGD&TMechanical DesignFDA RegulatoryMedical DevicesTolerance Analysis
About the role
- Bring your mechanical engineering expertise to Sentec's growing Sustaining Engineering team and help shape the future of respiratory care.
- Conduct engineering analyses, including tolerance stack-ups, material selection, and DFM/DFA.
- Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth.
Responsibilities
- Perform root cause investigation, failure analysis, and testing for post-market surveillance and CAPA activities.
- Define or revise user needs, design inputs, and product requirements as needed for design or regulatory compliance updates.
- Support verification and validation testing to ensure the product meets design requirements, and assist with risk management activities such as FMEA and hazard analysis.
- Ensure all designs comply with applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, ISO/IEC 60601).
- This is an exciting opportunity to partner with cross-functional teams, solve meaningful engineering challenges, and help improve the manufacturability and performance of Sentec's respiratory devices.
- You will investigate and analyze complex issues, develop practical and innovative solutions, and take ownership of engineering assignments that support the continued success, reliability, and growth of our products.
Requirements
- GD&T, tolerance analysis, DFM/DFA, and materials Familiarity with ISO 13485 and FDA design controls preferred Ability to develop a working knowledge of standards and regulations required.
Nice to have
- Bachelor's degree in mechanical engineering preferred or equivalent work experience required.
- 3+ years' experience working as a Mechanical Engineer
Benefits
- Sentec focuses on delivering impactful healthcare products and improving patient care.
- Sentec is a Swiss-American medical device company specializing in respiratory care.
- Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.
- Qualifications/ Education: Bachelor's degree in mechanical engineering preferred or equivalent work experience required.
Company info
- Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas.
This listing is sourced directly from Sentec's careers page and normalized into a canonical job model.